Study Stopped
Enrollment rate insufficient to fully enroll study within the planned timeline.
Enhanced Medication Reconciliation For Serious Mental Illness
A Pilot Prospective, Randomized Controlled Trial Assessing Enhanced Medication Reconciliation With a Clinical Decision Support Tool in Patients With Serious Mental Illness.
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study is to evaluate the clinical utility of a decision support tool, the Patient Medication Profile(TM), developed by Sano Informed Prescribing on medication reconciliation and identification of drug-related problems in patients with serious mental illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2019
CompletedJanuary 25, 2019
January 1, 2019
11 months
May 25, 2017
January 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medical record accuracy
The "Final Medication List" (medications in EHR at final visit) will be compared to the detected medications as summarized in the Patient Medication Profile at final visit (approx 3 months). For each patient, the proportion of detected medications that are not in the medication list will be calculated, excluding OTC medications from the analysis. Medical record accuracy in the intervention and control groups will be compared.
3 months
Secondary Outcomes (3)
Automated vs. manual pharmacist-led medication reconciliation
0 months
Drug Related Problem Identification and resolution
3 months
Adherence to prescribed medications
3 months
Study Arms (2)
Enhanced Medication reconciliation
EXPERIMENTALMedication reconciliation with pharmacist using electronic health records, pharmacy dispensing data and Sano Patient Medication Profile(TM)
Standard Medication reconciliation
NO INTERVENTIONMedication reconciliation with pharmacist using electronic health records and pharmacy dispensing data only
Interventions
The Sano Patient Medication Profile (PMP) is a graphical report comparing prescribed medications to LC/MS/MS-detected drugs from patient blood samples
Eligibility Criteria
You may qualify if:
- Current insurer is UPMC Health Plan
- Currently active in CRS clinic
- Prescribed four or more medications as indicated by pre-study Health Plan Medication List
- Able to provide informed consent for present study
You may not qualify if:
- Not competent to give informed consent in the opinion of the investigator
- Having had a previous medication reconciliation by the clinical pharmacist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Precera Bioscience, Inc.lead
- University of Pittsburgh Medical Centercollaborator
Study Sites (1)
Western Psychiatric Institute and Clinic of UPMC
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2017
First Posted
May 30, 2017
Study Start
February 27, 2018
Primary Completion
January 21, 2019
Study Completion
January 21, 2019
Last Updated
January 25, 2019
Record last verified: 2019-01